Ignite Creation Date:
2024-05-06 @ 6:40 PM
Last Modification Date:
2024-10-26 @ 2:52 PM
Study NCT ID:
NCT05740280
Status:
SUSPENDED
Last Update Posted:
2023-05-26
First Post:
2023-02-05
Brief Title:
iCP-NI - Safety Tolerability Pharmacokinetic and Immunogenicity Study in Healthy Male and Female Subjects
Sponsor:
Cellivery Therapeutics Inc
Organization:
Cellivery Therapeutics Inc
Study Overview
Official Title:
iCP-NI - A Phase 1 Double Blind Placebo Controlled Single and Multiple Intravenous Infusion Safety Tolerability Pharmacokinetic and Immunogenicity Study in Healthy Male and Female Subjects
Status:
SUSPENDED
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The Sponsor has put the study on hold and will recommence in due time
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a Phase 1 double-blind randomized placebo-controlled study to investigate single and multiple intravenous infusions of improved cell-permeable nuclear import inhibitor iCP NI in healthy subjects
Detailed Description:
Improved cell-permeable nuclear import inhibitor iCP-NI is a synthetically manufactured cell-penetrating peptide which has been developed by fusion of advanced macromolecule transduction domain of hydrophobic cell-permeable peptide and nuclear factor kappa-light- chain-enhancer of activated B cells NF-κB-derived nuclear localization sequence
The production and secretion of cytokines from innate immune cells are critical responses to inflammation and infection in the body
iCP-NI is a binding competitor that inhibits the interaction of nuclear transfer material proteins such as IATF NF-BB STAT AP-1 NFAT and importin alpha5 inhibiting the nuclear transport of IATF to prevent inflammatory cytokine transcription
This study is the first-human clinical trial for iCP-NI which is intended to evaluate the safety tolerability pharmacokinetics pharmacodynamics and immunogenicity of iCP-NI
The production and secretion of cytokines from innate immune cells are critical responses to inflammation and infection in the body
iCP-NI is a binding competitor that inhibits the interaction of nuclear transfer material proteins such as IATF NF-BB STAT AP-1 NFAT and importin alpha5 inhibiting the nuclear transport of IATF to prevent inflammatory cytokine transcription
This study is the first-human clinical trial for iCP-NI which is intended to evaluate the safety tolerability pharmacokinetics pharmacodynamics and immunogenicity of iCP-NI
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None